Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial

Ain Shams University

Status: Not yet enrolling

Conditions: Prevention of Postoperative Adhesions

Treatments: Drug: Normal saline; Drug: Actrapid insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT07007130

Dr Sayed Elakhras study

Details and patient eligibility

About

Adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. Intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. This trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.

Full description

This is a prospective, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy of intraperitoneal insulin administration at the end of laparoscopic surgery in women with insulin resistance, aiming to reduce postoperative adhesion formation. The study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-40 years
• Diagnosed insulin resistance (e.g., HOMA-IR >2.5 or fasting insulin >15 uIU/mL)
• Indicated for laparoscopy for infertility or pelvic pain
• BMI 20-35 kg/m²
• Able and willing to give informed consent

Exclusion criteria

• Diabetes mellitus requiring pharmacologic treatment
• History of peritonitis or major abdominal surgery in the past 6 months
• Known allergy or sensitivity to insulin
• Chronic steroid or immunosuppressive use
• Pregnancy or lactation
• Participation in another clinical trial within the last 3 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Intervention group

Active Comparator group

Treatment:

Drug: Actrapid insulin

Control group

Sham Comparator group

Treatment:

Drug: Normal saline